COLONOVIDEOSCOPE CF-H170IRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of COLONOVIDEOSCOPE (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus colonoscope is named in 267 adverse event reports, with no deaths and 2 injuries. The reports mostly describe scopes that were not cleaned adequately during reprocessing, along with transmission problems, contamination and poor image quality. One open recall, from September 2023, concerns repaired scopes that may have been returned with water left in the channel, which could raise the risk of infection.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 272
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 04953170334184), received between Oct 2, 2020 and Sep 30, 2026 — classified as 2 injuries, 270 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (147 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0329-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately147
- Communication or Transmission Problem28
- Device Reprocessing Problem20
- Contamination16
- Poor Quality Image14
- Erratic or Intermittent Display10
- No Display/Image10
- Residue After Decontamination9
Patient problems
- No Clinical Signs, Symptoms or Conditions267
- No Consequences Or Impact To Patient3
- Bowel Perforation1
- Burn(s)1
Recent adverse event reports
The 25 most recent of 272 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Poor Quality Image
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, it was observed that noise occurred in the image. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941997 ↗MalfunctionSep 28, 2026Communication or Transmission Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, a scope communication error (B31) was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910701 ↗MalfunctionSep 9, 2026Communication or Transmission Problem; Failure to Clean Adequately
The customer reported Prompts Scope communication error B30 during maintenance involving an Olympus colonovideoscope. Additionally, during the initial evaluation of the device, Auxiliary water channel flushes out sewage was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696057 ↗MalfunctionAug 28, 2026Erratic or Intermittent Display; Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506128 ↗MalfunctionAug 20, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50345989 ↗MalfunctionAug 19, 2026Poor Quality Image
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50334099 ↗MalfunctionAug 18, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50309247 ↗MalfunctionAug 16, 2026Erratic or Intermittent Display
The customer returned the Colonovideoscope to the service center for a separate issue. During the device analysis, the service technician identified occasional stripes on the image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266992 ↗MalfunctionAug 14, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50257900 ↗MalfunctionAug 12, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229588 ↗MalfunctionAug 7, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169005 ↗MalfunctionAug 4, 2026Melted
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130970 ↗MalfunctionAug 3, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112112 ↗MalfunctionJul 20, 2026Poor Quality Image
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT NOISE IMAGE OCCURRED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25877098 ↗MalfunctionJul 13, 2026Overheating of Device
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT BURN ON C-COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25796931 ↗MalfunctionJul 10, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT FOREIGN MATTER IS COMING OUT OF THE END DUE TO DAMAGE TO THE JET TUBE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25787543 ↗MalfunctionJun 26, 2026Communication or Transmission Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN IDENTIFIED A B31 SCOPE COMMUNICATION ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633248 ↗MalfunctionJun 22, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED SCOPE COMMUNICATION ERROR B30 DURING INSPECTION PRIOR TO USE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25579140 ↗MalfunctionJun 10, 2026Overheating of Device
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THE DEVICE HAD BURNT C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25462046 ↗MalfunctionJun 9, 2026Poor Quality Image
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE EXHIBITED A NOISY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25449441 ↗MalfunctionJun 9, 2026Corroded
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING EVALUATION OF THE DEVICE, THE LIGHT GUIDE COVER GLASS WAS CORRODED. THE SERVICE REPAIR TECHNICIAN INDICATED THE MOST LIKELY CAUSE WAS COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25442954 ↗MalfunctionMay 31, 2026Erratic or Intermittent Display
THE CUSTOMER REPORTED A BLACK LINE VISIBLE ON THE SCREEN DURING INSPECTION FOR USE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25345286 ↗MalfunctionMay 27, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25309324 ↗MalfunctionMay 26, 2026Failure to Clean Adequately
THE COLONOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF LEAKAGE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, STICKINESS ON THE GRIP WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285097 ↗MalfunctionMay 8, 2026Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A B30 SCOPE COMMUNICATION ERROR UPON POWER UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123249 ↗
Other Colonoscope and accessories, flexible/rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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